摘要
对于临床试验而言,研究方案的科学性至关重要。作者总结了2019年以来首都医科大学附属北京中医医院100余项科研项目的科学性审查工作,汇总分析了研究设计中的一些共性问题,发现存在研究设计类型单一、结局指标选择欠妥、合并用药描述欠清晰等问题,同时探讨了以上问题的解决对策,以期为未来中医药临床研究方案设计提供有意义的参考。
Research protocols are essential for clinical trials. More than 100 scientific research projects since 2019 were reviewed regarding scientific examination in Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, in order to summary and analyze some common issues existing in research design. The results indicated that the problems in common included single type of trial design, inappropriate choice of the outcome measures and unclear statement of the concomitant medication. The authors put forward the countermeasures to solve the above problems, hoping to provide meaningful references for clinical trial design in the future.
作者
韩芳
刘宝利
程金莲
刘清泉
HAN Fang;LIU Bao-li;CHENG Jin-lian;LIU Qing-quan(Office of Academic Research,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第7期635-638,共4页
Chinese Journal of New Drugs
基金
国家“重大新药创制”科技重大专项资助项目(2019ZX09734001)
北京市属医院科研培育计划课题(PG20181001,PZ2020013)。
关键词
临床研究
科学性审查
方案设计
研究者发起的研究
clinical trials
scientific examination
study design
investigator initiated trials
